Tissue receiving bag and set for surgery comprising a tissue receiving bag

ABSTRACT

The invention relates to a tissue receiving bag for use in surgery, especially laparoscopic surgery, wherein the bag comprises at least one tissue receiving opening for receiving tissue and/or an instrument opening, especially a morcellator opening, wherein the bag comprises at least one further opening into the bag, wherein a flexible tube extends from said further opening having a free end comprising an insertion opening for inserting an instrument into the bag, wherein the bag preferably is inflatable.

RELATED APPLICATIONS

This application is a 35 U.S.C. § 371 national phase application ofPCT/NL2016/050162 (WO 2016/144170) filed on Mar. 9, 2016, entitled“Tissue Receiving Bag and Set for Surgery Comprising a Tissue ReceivingBag”, which application claims the benefit of Netherlands ApplicationNo. 2014426, filed Mar. 9, 2015, which is incorporated herein byreference in its entirety.

The invention relates to a tissue-receiving bag for use in surgery,especially laparoscopic surgery. The invention further relates to a setfor surgery, especially laparoscopic surgery, comprising atissue-receiving bag.

During surgery for removing tissue from a human or animal body, use canbe made of a tissue-receiving bag for containing the tissue before andduring removal of the tissue. An instrument can be used for morcellationof the tissue within the tissue receiving bag, in order to be able toeasily remove the tissue even through a relatively small opening, suchas for example during endoscopic surgery. Such instrument can bereferred to as a morcellator.

WO2013/093030 discloses a tissue-receiving bag, which is referred to asa pneumoperiteneum device, for containing and morcellating tissue insidea cavity in a human body. In this device a collar is placed in anincision, through which collar the bag is introduced into the cavity.Tissue is cut from the body in the cavity using instruments insertedthrough said collar, for example inserted through a multi port closureplaced on said collar, which tissue is then introduced in the bagthrough an opening. Then the opening is pulled out through the incisionand, after removal of the closure, mounted on the collar, after whichthe closure is placed back, locking the neck of the bag 1 in place.Then, the tissue inside the bag can be treated by instruments insertedthrough the closure. The bag can be inflated inside the cavity when theclosure is in place.

WO2013/075103 discloses a tissue receiving bag, comprising a tissuereceiving opening closable by a zip lock® type closure. Severalinstrument ports have been provided in a wall of the bag.

Since April 2014 the Food and Drug Administration (FDA) discouraged itsuse for uterine procedures, issuing a warning that morcellators mayspread occult cancer in the course of fibroid removal. A second warningwas followed in November of the same year. One of the major suppliers ofmorcellator subsequently suspended sale of its morcellators until therole of morcellation will have been clarified by the FDA and the medicalcommunity, and later pulled its morcellators from the market.

In the same statement the FDA released a statement discouraging the useof power morcellators in patients seeking hysterectomy (removal ofuterus through lower abdomen) and myomectomy (surgery to remove uterinefibroids—also called leiomyomas) procedures. The FDA suspects thatnearly 1 in 350 patients, that are undergoing these procedures with thepower morcellators, are at risk for having unsuspected uterine sarcoma,which can have major life altering consequences that the patient shouldnot have to suffer for.

Morcellation is associated with spreading of cellular material of themorcellated tissue. In gynecologic surgery for benign pathologies therehas been reported that there is approximately a 0.09% risk of anunexpected leiomyosarcoma. After morcellation 64% of such cases maydevelop disseminated disease which is of particular concern because ofthe considerable mortality of leiomyosarcoma. Morcellation of the morefrequent benign leiomyoma variants may also cause disseminated disease,which while not associated with increased mortality is frequentlyinoperable and therefore much more difficult to manage than the originaldisease.

Thus there is a need for equipment suitable for surgery for removal oftissue from a human or animal body, using a tissue receiving bag inwhich the tissue can be safely morcellated and contained inside the bag,before and during removal of the morcellated tissue from the body. Suchequipment may include an improved morcellator.

There is furthermore a need for a tissue-receiving bag for use insurgery including morcellating tissue inside the body, especially insidethe bag, containing the morcellated tissue. Preferably such atissue-receiving bag is sufficiently safe to aid in overcoming theobjections raised by the FDA.

Furthermore there is a need for improved surgery including a morcellatorstep of tissue to be removed from a human or animal body.

Some of these needs can be fulfilled at least in part by products,systems and methods according to this disclosure.

In an aspect a tissue-receiving bag for use in surgery, especially laparoscopic surgery, according to this disclosure can be inflatable andcomprises at least one tissue receiving opening for receiving tissue,and an instrument opening. The tissue-receiving opening can be the sameas the instrument opening or they can be separate openings, spaced apartfrom each other. At least one instrument opening can be a morcellatoropening. The bag comprises at least one further opening into the bag,wherein a flexible tube extends from said further opening. The said tubehas a free end comprising an insertion opening for inserting aninstrument into the bag.

With an operating bag according to the disclosure a morcellator can beinserted into the bag through the morcellator opening whereas thefurther instruments can be inserted into the bag through the at leastone further opening. The further instrument can be inserted through theflexible tube, for example when the free end thereof has been pulled outof the body in which the bag has been inserted. Preferably theinstrument opening and the at least one further opening are positionedon the bag some distance apart. The tube preferably has a length, atleast in an extended position, such that the free end thereof can bepulled out through a lap aroscopic incision in the body spaced apartfrom an opening through which the morcellator instrument can be insertedinto the bag.

Preferably the tube is arranged such that the further instrument can beinserted into and pulled out of the tube and hence of the bag fromoutside the body. Preferably the instrument can at least be pulled outof the tube and hence out of the bag without touching the body, suchthat the risk of transfer of tissue, such as body cells, from theinstrument to the body.

Preferably the free end of the tube can be closed outside the body whenextending out of the body through an incision, before being retractedinto the body through said incision. Thus the risk of tissue, such asbody cells leaving the bag through the said opening is mitigated andcontamination is prevented substantially.

A bag according to this disclosure can have multiple such openings towhich a tube is or can be connected, especially a flexible tube. Eachtube can be an integral part of the bag.

A tissue bag according to the present disclosure preferably is suitablefor at least introduction into a human or animal body through a firstopening in the body, especially a first incision, introducing tissueinto the bag through a tissue opening, closing the tissue opening,pulling a free end of the at least one tube out of the body through asecond incision, especially a second laparoscopic incision, introducinga morcellator into the bag through the instrument opening andintroducing a further instrument into the bag through the free end ofthe tube. Preferably the bag is suitable for containing morcellatedtissue inside the bag, closure of the free end of the at least one tubeoutside the body, retracting at least one tube into the body through thesecond incision and retracting the bag from the body through the firstopening.

In this way a tissue-receiving bag can be provided with a tissuereceiving opening and an instrument opening, especially a morcellatorinsertion opening, spaced apart from the tissue receiving opening. Thetissue receiving opening can be provided with closing means such as azipper, Ziploc® type closure, adhesive, Velcro® type closure or thelike, for closing the tissue receiving opening, especially inside a bodycavity after receiving tissue inside the bag through said tissuereceiving opening. The tissue receiving opening when fully open may belarger that the instrument opening. The instrument opening may beprovided by a flexible tube or neck of the bag having a cross sectionsmaller than that of the tissue receiving opening, when fully open. Thebag can be designed such that during use the instrument opening can beheld outside a body cavity, whereas the rest of the bag has beeninserted into said cavity through an incision in the body, wherein thetissue receiving opening can be opened and closed inside said body andinstruments can be inserted into and through the bag, extending throughthe instrument opening and the tissue receiving opening when open.

An operating set according to this disclosure can comprise a bag whichcomprises at least one tissue receiving opening for receiving tissue,and an instrument opening, especially a morcellator opening. The bag maycomprise at least one further opening into itself, wherein a flexibletube extends from said further opening. The tube has a free endcomprising an insertion opening for inserting an instrument into thebag. The set further comprises at least a morcellator instrument. Thebag and/or the instrument comprise at least one indicator for preventingthe morcellator puncturing the bag. The set preferably is especiallysuitable for laparoscopic surgery.

The operating set may further comprise at least one further instrument,insertable through a tube and further opening of the bag, wherein thefurther opening and/or the tube can be sealingly closed around saidfurther instrument when extending through said tube and/or furtheropening. The further instrument preferably is one of an endoscope, acamera, a catheter, a cannula, tongs or scissors.

In an aspect a method disclosed for morcellating surgery comprises usinga tissue-receiving bag which comprises at least one tissue receivingopening, and an instrument opening, especially a morcellator opening,wherein the bag comprises at least one further opening into the bag,wherein a flexible tube extends from said further opening having a freeend. This method may comprise at least the steps of introduction of thetissue receiving bag into a human or animal body, through a firstopening in the body, especially a first incision, introducing tissueinto the bag through the tissue opening, closing the tissue opening,pulling a free end of the at least one tube out of the body, preferablythrough a second incision, especially a second laparoscopic incision,introducing a morcellator into the bag through the instrument openingand introducing a further instrument into the bag through the free endof the tube.

The method may further comprise the steps of morcellating tissue insidethe bag, containing the morcellated tissue inside the bag, closing thefree end of the at least one tube outside the body, retracting the atleast one tube into the body through the second incision and retractingthe bag from the body through the first opening.

In further elucidation of the present invention embodiments of thepresent disclosure, such as embodiments of a tissue-receiving bag, anoperating set and an operating method shall be described hereafter, withreference to the drawings. In the description a tissue-receiving bag mayalso be referred to as a morcellator bag. Therein shows:

FIG. 1 schematically an embodiment of a tissue-receiving bag, inperspective view;

FIG. 2 schematically an embodiment of a tissue-receiving bag, inperspective view, having tubes provided at further instrument openings;

FIG. 3A-C schematically three steps of retracting an instrument from atube of a tissue receiving bag;

FIG. 4 schematically in cross section part of a tissue receiving bag,with a tissue receiving opening and a further instrument opening;

FIG. 5 schematically an instrument, for example a morcellator insertedinto a tissue receiving bag according to the disclosure, provided withmeans for monitoring the position of an end of the instrument relativeto the wall of the bag.

FIGS. 6A and B an instrument with a tube provided along a shaft thereof.

In this description, embodiments of the invention will be described withreference to the drawings by way of example only. These embodimentsshould by no means be understood as limiting the scope of thedisclosure. At least all combinations of elements and features of theembodiments shown are also considered to have been disclosed herein. Inthis description the same or similar elements and features will bereferred to by the same or similar reference signs.

In this description expressions of orientation such as top, bottom,vertical et cetera are used for convenience only and refer to theorientation of the module as seen in the accompanying drawings. Suchexpressions are not to be regarded as limiting the orientation of themodule in use, and indeed, as will be described below, bags andinstruments such as morcellators according to the description can beused in other orientations.

A tissue receiving bag 1 according to the disclosure can be used forsurgery, especially but not limited to laparoscopic or minimal invasivesurgery, for removal of tissue from a human or animal body, such as forexample but not limited to hysterectomy, removal of cancerous and/orbenign tissue or cists, or of organs. Tissue may for example and notexclusively be all or part of the uterus, ovaries, fibroids, spleen,kidneys, intestine, or any dissected tissue to be removed safely fromsaid body.

A tissue receiving bag according to this disclosure can preferably beclosed during and after surgery such that at least all parts of the bag,including the or each tube, that pass into and/or through the body of apatient are firmly closed when tissue is treated inside the bag andretrieved from the body from the bag or with the bag, whereas the atleast one additional tube provides access into the bag when so desired.No tissue matter can therefore escape into the body from the bag whenthe tissue receiving opening has been closed.

FIG. 1 shows schematically a tissue-receiving bag 1 for use in surgery,especially laparoscopic surgery. The bag 1 can be made of plastic, suchas transparent plastic, or for example of rubber. The bag 1 is flexible,such that it can be collapsed to be inserted through an incision into anopening or cavity in a human or animal body B. The bag 1 may beinflatable, in a suitable manner, as will be explained. The bag 1 maycomprise at least one tissue receiving opening 2 for receiving tissue T,for example tissue to be removed from the body B. The bag 1 may compriseat least one instrument opening 3, for introducing at least oneinstrument 15. The at least one-instrument opening 3 may be amorcellator opening 3.

As shown in FIG. 2 the bag 1 can comprise at least one further opening 4into the bag 1. A flexible tube 5 extends from said further opening 4having a free end 6 comprising an insertion opening 7 for inserting aninstrument 8 into the bag 1.

In this description a tube 5 should be understood as meaning at least atubular element which is at least partly flexible and preferably made ofplastic or rubber. A tube 5 can be an integral part of the bag 1 or canbe connectable to the bag 1, for example using a known coupling element,or can be mounted to the bag 1, for example by sealing, welding, gluingor any other suitable means. A tube 5 can for example be pleated, suchthat in a first position, as for example shown in FIG. 1, it has arelatively short length Lin between the free end 6 and the opening 4,whereas in a second position, for pulled into an extended state, it hasa far longer length Lout. A tube 5 may have an internal cross section Dwhich is smaller than the length Lout when in said extended state. Thecross section D may be relatively small compared to the size of thetissue receiving opening when fully opened. In a bag 1 having multipletubes 5, the tubes may have all the same or different dimensions. In anextended state of the tube 5 the tube may have a length Lout between thefurther opening 4 and the free end 6 which is at least five times thediameter D4 of the further opening 4. The tube 5, at least in theextended state of the tube 5, has a length Lout suitable for during usebringing the free end 6 of the tube 5 outside a human or animal body Bthrough a laparoscopic incision 9 when the bag 1 has been inserted intoa body cavity C of the human or animal body B. A longitudinal directionof the tube 5 should be understood as meaning a direction between theopening 4 to which it is connected and the free end 6 thereof.

The free end 6 of the tube 5 may be provided with at least one closingelement 10 for closing the free end 6 of the tube 5 and preferably forsealing the tube 5 around an instrument 8 when inserted into the tube 5through the free end 6 or at least through the insertion opening 7. Suchclosing element 10 can for example be a tie rope or an elastic band. Inembodiments the closing element 10 can comprise a gel port or the likeself-closing element. Preferably the element 10 closes air tight aroundthe instrument. In embodiments the end 6 can be provided with a seal 10cooperating with a seal provided on the instrument 8, for examplecomparable to a Luer lock-type connection.

In embodiments the free end 6 of the tube 5 is closed, at least prior touse of the bag 1, by at least one of a tube portion, a closure or avalve. In an embodiment the free end 6 may be closed by part of the tube5 itself, for example a seal of the tube such as shown in FIG. 3 bypressing the tube flat and sealing the wall thereof against itself. Theclosed end can for example be severed in order to provide access to theinsertion opening 7, for example by cutting off the free end of the tube5.

In embodiments the further opening 4 can comprise a closure 11. Theclosure 11 preferably is a self-closing closure or seal for sealingaround an instrument 8 inserted through said further opening. Suchclosure 11 can for example be a gel port, as known in the art, or a duckbill type valve as shown in FIG. 3.

In embodiments the tube 5, especially at least the free end thereof canbe designed such that after removal of the instrument 8 from the tube 5the free end 6 can be closed again, in order to avoid gas and/or fluidsand, especially, bodily tissue such as but not limited to body cellsleaving the bag through said tube 8. In embodiments the closing 10 asdiscussed can be used for reclosing said end 6. The closing element 10can for example be an elastic band or string that can be pulled tightaround the instrument 8 and after removal of the instrument. Inembodiments a closure element 10 can be a self-closing element, such asa duck bill type valve, which can be pushed open when inserting aninstrument 8 but will be pushed closed, for example by gas inside thebag, when the instrument is not present in the tube 5.

FIG. 3 shows an embodiment of part of a tube 5 including a free end 6thereof, which comprises at least two closures and/or seals 10A, 10B,spaced apart longitudinally, for closing the tube and/or sealing againstan instrument extending through said tube.

During use after removal of an instrument 8 from the tube 5 first thefree end 6 can be folded or pushed inward back into the tube 5 afterwhich a closure 10, especially one of at least two closures 10,especially the second closure 10B can be closed or pulled tight, closingthe tube 5 and securing the free end 6 inside the tube 5. Since the onlypart of the tube 5 that could be in contact with the instrument 8 andmight thus be contaminated with for example body cells is the inside ofthe tube 5 and possibly the edge of the insertion opening 7 or adirectly adjacent part of the free end 6, by confining this inside thetube itself, closed off from the environment, contamination of theenvironment is prevented.

If two closures 10A, 10B are provided, one of the closures 10A,especially the closure closest to the opening 4 can be closed before theinstrument 8 is fully retracted (FIG. 3A), preventing tissue fromleaving the tube 5 and possibly preventing deflation of the bag 1. Thenthe other closure 10B can be closed in a manner as described here above,by first folding or pushing the free end 6 back into the tube 5 (FIG.3B) an then closing the second closure 10B (FIG. 3C).

In embodiments the bag is provided with a series of further openings 4.A flexible tube 5 can extend from some or each further opening 4. Inembodiments each further opening 4 can be spaced apart from the tissuereceiving opening 2 and from the instrument opening 3. This will easeworking on tissue within the bag 1 with different instruments, such as amorcellator and for example a camera, scissors, graspers or the like,from different angles.

The tissue receiving opening 2 is preferably provided with a closingmechanism 12 for closing the opening 2 after tissue T has been receivedinside the bag 1. Such closing mechanism can for example be a zipper,Ziploc® type closure, adhesive strips, Velcro® type locking or any suchsuitable means for closing the opening 2, preferably air and liquidtight. Alternatively or additionally the bag 1 can be foldable such thatthe opening 2 can be closed after receiving the tissue T.

In embodiments a further tube 13 can extend from or can define theinstrument opening 3. Said further tube 13 and/or the instrument opening3 can comprise a closure and/or seal 14 for closing and sealing the tube13 around an instrument 15 extending through said tube and/or forclosing the tube 13 when such instrument 15 has not been inserted intothe opening 3 or is retracted from said instrument opening 3. The tube13 will have a longitudinal length L13 making it easy to keep an end 16of the tube 13 outside the body or at least outside an incision 9through which the bag 1 is inserted, in order to provide easy accessinto the bag 3, easy connection to the bag 1, for example forinstrumentation or for removal of the bag 1 from a cavity C. Moreoverthis may prevent contamination of the incision 9 when an instrument 3 isretracted or when the bag 1 is removed.

In embodiments a closure and/or seal 14 at the opening 3 of the bag 1can be an integral part of the bag 1. In embodiments a closure and/orseal 14 at the opening 3 can be a multi port closure as conventionallyused with tissue receiving bags 1 of the prior art. Such multi portclosure is for example known from WO2013/093030. Such closures are wellknown in the art, such as for example but not limited to TriPort15 orSILS ports.

In preferred embodiments a tissue receiving bag 1 according to thedisclosure is suitable for at least introduction into a human or animalbody B through a first opening in the body, especially a first incision9, introducing tissue T into the bag through the tissue opening 2 andclosing the tissue opening 2. A free end 6 of at least one tube 5 canthen be pulled out of the body B, preferably through a second incision17, especially a second lap aroscopic incision 17. The free end canthereby be brought outside the cavity C and preferably also outside thebody B. During surgery then at least part of an instrument such as forexample a morcellator 15 can be introduced into the bag 1 through theinstrument opening 3, whereas a further instrument 8 can be introducedat least in part into the bag 1 through the tube 5, by inserting itthrough the opening 7 of the tube 5. If several such tubes 5 areprovided several entries into the bag can be created in this way.

Preferably the bag 1 is further suitable for morcellation of and/orotherwise treating the tissue T inside the bag and containingmorcellated tissue T inside the bag 1. Preferably the free end 6 of theat least one tube 5 outside the body B can be closed during and/or afterretraction of the relevant further instrument 8 from said tube 5,preferably gas and liquid tight. Then the at least one tube 5 can beretracted into the body through the relevant second incision 17, backinto the cavity C in which the bag 1 is situated. The bag 1 can beretracted from said cavity C and the body B through the first opening orincision 9. Since the free end 6 of the tube 5 has been closed prior toretraction into the cavity, contamination of the cavity C by any tissuerelated matter, such as cells is prevented, since this matter cannotleave the bag 1.

Alternatively the instrument opening 3 can be closed and the bag beretracted through the same or a second incision 17 or further incisionor natural or man made body opening.

It is preferred that the instrument 8 is retracted into the tube 5 inpart, such that it can be closed between an end 8′ of the instrumentclosest to the main volume V of the bag 1 and said main volume V, beforeretracting the instrument fully from the tube, preventing matter, suchas tissue cells being forced out of the bag before closing the tube 5.Then, when the instrument 8 has been retracted fully, preferably thefree end 6 of the tube 5 is inserted into the tube 5, for example pushedor folded back, where after the tube 5 is again closed at the then freeend 6A thereof, containing the original free end 6 within the tube 5,between the two closures. Thus contamination of the body B with matterfrom the bag is even better prevented, especially during retractionthereof into the cavity C and when being pulled out through the firstopening or incision 9. For such method especially but not exclusively abag 1 as for example shown in FIG. 2 would be suitable.

In embodiments the bag 1 can be inflatable. In embodiments the bag 1 canbe inflatable by inserting gas such as air into the internal volume V ofthe bag 1, for example through one of the openings 2, 3, 7. Obviouslysuch bag 1 then preferably is air tight, including closures of allrelevant openings. By inflating the bag 3 the internal volume V of thebag 1 can be kept open, which at least facilitates working inside thebag 1 by creating a substantially unobstructed working area. Moreoverthis reduces the risk of the instruments 8, 15 damaging the bag 1,especially puncturing the wall 18 of the bag 1 since the bag 1 will beexpanded.

In embodiments, as for example shown in FIG. 4, a tissue-receiving bag 1can have a multi layered wall part 18. In embodiments a gas and/or fluidcan be provided between at least two of the layers 18A, 18B of said wallpart 18. In embodiments the gas or fluid inserted in between the layers18A, 18B can be used for inflating the bag 1. In such embodiment theinternal volume V may be kept at substantially atmospheric pressure orat least does not to be pressurized. Alternatively or additionally theat least two layers 18A, 18B can be used for enforcing the bag 1. Inembodiments the space 19 between two layers 18A, 18B can be used fordetecting a leak in one of the two layers 18A, 18B, for example bymeasuring the pressure of the gas or fluid in said space 19. When saidpressure drops the integrity of at least one of said layers 18A, B mayhave been compromised, for example by puncturing the inner wall 18A byan instrument, such as the morcellator. Alternatively the bag can beobserved, for example using a camera, for fluid flowing into the innervolume V and/or into the cavity C from the space 19. To which endpreferably the fluid or gas is colored or at least made detectable bythe camera or a sensor supplied for the same, such that fluid or gasescaping from the space 19 can easily be detected.

According to the invention an operating set, especially for laparoscopic surgery can comprise a bag according to any one of theprevious claims and at least one morcellator instrument, wherein the bagand/or the instrument comprise at least one indicator for preventing themorcellator puncturing the bag.

In embodiments of a tissue receiving bag, such as a bag 1 as disclosedin this description or as known in the art, at least part 18C of a wall18 of the bag 1 is electrically conductive. An instrument 8, 15, such asa morcellator, to be used inside the bag 1 can then be provided with atleast one appropriate contact 20, such that when said contact 20 isbrought into contact with the electrically conductive wall part 18 anelectric circuit is closed and an alarm 25 given, for example audibleand/or visible, and/or the instrument is shut off. This can for examplebe indicative for a situation in which a part of the instrument 8, 15 istoo close to said wall, risking puncture or otherwise damage of the bag1. Alternatively or additionally said sensor can be or comprise acontact or pressure sensor. Alternatively or additionally the wall 18 ofthe bag 1 can for example be at least partly reflective forelectromagnetic waves, such as but not limited to light or sound, e.g.ultra sound, transmitted from a transmitter 21 provided on theinstrument 8, 15, wherein a sensor 22 is provided for receiving wavesreflected from said reflective wall part 18. Based on the waves detectedby said sensor 22 then the distance of a relevant part of the instrument8, 15, for example the distance between the wall 18 of the bag 1 and amorcellator head 15A can be deduced, which can again be indicative for asituation in which a part of the instrument 8, 15 is too close to saidwall, risking puncture or otherwise damage of the bag 1. This can beused for example for giving an alarm 25 and/or for shutting off theinstrument 8, 15.

In more general terms an operating set 23 of a tissue receiving bag 1for example but not limited to a bag 1 according to this disclosure andan instrument 8, 15 can be designed such that at least one of the bag 1and/or the instrument 8, 15 comprise at least one indicating system 18,20, 21, 22 for preventing the instrument 8, 15, especially a morcellatorpuncturing the bag 1. This may prevent the risk of tissue and/or bodyfluids, such as morcellated tissue, cells or the like to leak from thebag 1 back into the body, which could result in infection or spreadingcells which may be cancerous or otherwise detrimental to the patient'shealth.

In these embodiments the indicating system 18, 20, 21, 22 can bedesigned to measure or otherwise detect a distance between a cutting orpuncturing end of the relevant instrument and a wall part 18 of the bag1 close thereto, such that if said distance is reduced below apredefined limit an alarm is given and/or the instrument 8, 15 is shutoff or is otherwise prevented from damaging said wall of said bag. Thesaid limit may be zero, meaning that said alarm is given or saidinstrument is shut off or brought into an idling state when a relevantpart of the instrument contacts the wall of the bag. For example as longas said instrument contacts said bag.

An operating set 23 according to this disclosure can comprise atissue-receiving bag 1 and at least one instrument, especially amorcellator 15. Such an operating set can further comprise at least onefurther instrument 8 insertable through a tube 5 and a further opening 4of the bag 1. The further opening 4 and/or the tube 5 can preferably besealingly closed around said further instrument 8 when extending throughsaid tube 5 and/or further opening 4. Such further instruments can forexample be one of but not limited to an endoscope, a camera, a catheter,a cannula, grasper or scissors. An example of a morcellator can be aStorz morcellator.

With an operating set 23 according to the disclosure surgery can beperformed, for example as follows.

After proper preparation of a patient 30 a first incision 9 is made inthe body B, opening into a body cavity C. The tissue-receiving bag 1 isfolded and then introduced into the cavity C through the first incision9. The instrument opening 3 is held outside the cavity C, a part of thebag 1, for example a further tube 13 forming a neck portion of the bag 1extending through the incision 9. Tissue T to be removed, for exampleand not limited to all or part of the uterus, ovaries, fibroids, spleen,kidneys, intestine, or any dissected tissue to be removed safely fromsaid body, is cut from the body B inside the cavity, for example byintroducing a dissecting instrument 8A into the body cavity C through asecond incision 17, in a known manner. The tissue T preferably is heldby an appropriate instrument 8B, such as graspers, during dissection, inorder to manipulate the tissue during dissection and to prevent thetissue T from dropping in the cavity C. In embodiments the instrument 8Bcan be inserted into the body cavity C through a third incision, butpreferably the said instrument 8B is inserted through the instrumentopening 3 or through a further opening 4, extending through the bag 1and out of the tissue receiving opening 2, such that after dissectionthe tissue can be retracted into the bag 1 through the tissue receivingopening 2 without for example having to transfer it to a furtherinstrument. In embodiments the bag could be moved over the tissue to bedissected prior to dissection, by moving the tissue-receiving openingover the tissue T and dissecting the tissue T inside the bag. In suchembodiment the dissecting instrument 8A could also be inserted into thebag through the instrument opening 3, or through a further opening 4,preferably in a manner as will be described hereafter.

After having received the tissue T inside the bag 1, the tissuereceiving opening 2 is closed, for example by the closing mechanism 12.Preferably the closure can be manipulated from the inner volume V of thebag 1. Alternatively the closure can be manipulated at least partly fromthe outside of the bag 1, for example by introducing an appropriateinstrument such as graspers through a further incision.

On the instrument opening 3 preferably a closure 14 is provided, such asfor example a multi port closure as indicated before, closing andsealing the opening 3. The bag 1 preferably is inflated by introducing agas such as air into the interior volume V and/or, if a multi-layeredwall is used, between two such layers 18A, B, as described. This willprovide a large inner volume V of the bag 1 allowing the surgeon(s)sufficient space to manipulate the tissue T inside the bag without beingobstructed by the wall 18 of the bag 1. The wall 18 of the bag 1 maypush outward the wall of the cavity C.

The dissecting instrument 8A will be retracted from the second incision17. An appropriate instrument, such as for example, graspers, will beinserted through a second incision 17, with which instrument an end 6 ofa tube 5 will be grasped such that it can be pulled out through thesecond incision 17, such that the tube 5 passes the incision and freeend 6 extends outside said body B or at least outside the cavity C. Ifthe end 6 and/or the opening 4 from which the tube extends is closed nogas or tissue can leave the bag through said tube 5. Such closure canfor example be obtained by one of the closures 10 or by an appropriateclosure at the opening 4, for example but not limited to a gel port or aduck bill type valve, as known from the art and for example described inWO2013/075103.

The free end 6 outside the body B may be severed, for example be cutoff, providing an opening 7 into the tube 5. Then an instrument 8, suchas for example but not limited to graspers, scissors, endoscope, lightsource, suction device, flushing device, cannula, catheter or the likecan be inserted into and through the tube into the inner volume of thebag 1. The instrument 8 will be shielded relative to the cavity C by thetube 5 and the bag 1. Preferably the tube 5 seals against an outside ofthe instrument 8 or appropriate seals are provided, for example a singleor multi port closure 14A provided by or mounted on the opening 7 or inthe opening 4, preventing gas and/or tissue such as cells or fluids topass along the instrument 8.

Obviously more than one such tube 5 can be pulled through one or moreincisions 9, 17, in a similar way, in order to provide different pointsof access into the bag 1 for instruments to be used during surgery. Eachincision 9, 17 is preferably a laparoscopic, minimal invasive incision.

After closure of the bag 1, especially the tissue receiving opening 2,and preferably after inflating the bag 1, a morcellator 15 can beinserted into the inner volume V of the bag 1, in order to morcellatethe tissue T inside the bag. Such morcellators (both electromechanicaland bipolar cutting) are well known in the art and shall not bediscussed here in any detail. In embodiments during morcellation of thetissue the morcellated tissue can be retrieved from the bag 1, forexample by suction and/or extraction with graspers through themorcellator itself and/or through a suction instrument inserted into thebag through a tube and further opening 4. Alternatively, the tissue,before, during and after morcellation can be contained by the bag 1,inside the inner volume thereof, to be removed from the cavity togetherwith the bag 1.

FIG. 5 shows the bag 1 inside the cavity C, tissue T contained insidethe bag 1 and a morcellator 15 and further instruments 8 insertedthrough the tube 13 and the tube 5 respectively.

When an instrument 8 is no longer necessary for use in the bag 1 it maybe retracted from the relevant tube 5. Preferably, to this end firstlythe instrument 8 is retracted following the procedure as described withreference to FIG. 3. The instrument is first retracted partly, such thatthe end 8′ is situated between the opening 4 and the opening 7 and,preferably, between the first and second closures 10A, 10B, preferablyin a part of the tube extending outside the relevant incision 9, 17 inbody B. Then the internal passage of the tube 5 between the end 8′ andthe opening 4 is closed off, for example by the first closure 10A. Thusgas and, especially tissue matter such as cells cannot pass said closure10A. Then the instrument may be retracted from the tube completely. Thefree end 6 of the tube 5 can then be pushed back into the inner passageof the tube 5, such that any tissue matter that might be transferredfrom the instrument onto an edge portion 6A of the tube is containedwithin the inner passage of the tube 5. Then the second closure 10B isclosed, locking said edge portion 6A within the tube 5.

When the bag 1 is to be retrieved from the cavity C any tube 5 used willbe closed as discussed. Then the bag 1 can be retrieved by pulling itout of the cavity C through one of the incisions 9, 17. Preferably thebag 1 is retrieved through the largest incision or the least conspicuousincision. The bag may also be inserted and/or retrieved per vaginam,through the Fossa Douglasi or through any orifice appropriate for theperformance of the surgical techniques, for example techniques now knownas Natural Orifice Translumenal Endoscpopic Surgery (NOTES®) surgery.The bag can for example be retrieved through the first incision 9. Insuch embodiment the or each tube 5 extending through another incision 17will be pulled back into the cavity C before being pulled out of thecavity C with the bag 1. Since the free ends 6 have been properlyclosed, the possibly contaminated portions 6A thereof being wellshielded, the risk of contamination of the cavity C is substantiallyeliminated.

In the embodiments of the method described the instrument opening 3 iskept outside the cavity C during the entire procedure. However it isalso possible to first insert the entire bag 1 into the cavity C,dissect the tissue and position it into the bag 1 and then pull theinstrument opening 3 back out through the first incision 9. This isespecially suitable of the instrument opening 3 is also the tissuereceiving opening 2, as is known in the art as for example described inWO2013/075103 and WO2013/093930. In such embodiments again one or moretubes connected to one or more further openings 4 may be pulled throughfurther incision(s) as described here above, before, during and/or afterbringing the instrument opening 3 back out through the first incision 9.

In embodiments for at least one and preferably all of the tubes 5 and/orfor the tube 13 a cytotoxic valve or seal, such as for example but notlimited to a gel port 36, 36A can be provided, preferably at a positionoutside the body B during surgery. Such cytotoxic provision can forexample be incorporated into or be provided by the ports 14 and/or 14Aor as separate provisions. In FIG. 5A these provisions 36, 36A areschematically shown as incorporated in the ports 14, 14A. During use andespecially during retraction of an instrument 8, 15 from the respectivetube 5, 13 a cytotoxic compound can be transferred to the instrument,for example through contact between the instrument and the cytotoxicprovision, such that cells attaching to the instrument will beinfluenced by said compound. The cell viability will deteriorate by saidcompound in a known manner. Examples of such compounds can for examplebe but are not limited to fluids or gels formed by or containing forexample one or more of the group of alcohol, iodine, betadine or anysuch known disinfecting or cytotoxic compound.

Preferably the cytotoxic provisions are mounted to or connected to orover the free end of the relevant tube 8, 13 outside the body, such thatthey can be removed from the relevant tube 5, 13 prior to the procedureas described, for example referring to FIG. 3 A-C, for retrieval of thebag 1 from the body B. Thus it is prevented that the cytotoxic compoundis brought into the body B.

As discussed one or each tube 5 may be a part separate from the bag 1and may be connectable to the bag 1, especially to a further opening 4permanently or temporarily. In embodiments the tube can be provided withan instrument 8 to be introduced into the bag. As shown in FIG. 6 a tube5 can be positioned over a shaft of an instrument 8. Preferably an end31 of the tube 5 is connected to the instrument 8, preferably at or nearthe tip 8′ thereof. When the instrument 8 is inserted through a secondincision 17, the tube 5 is taken along with it and is inserted into therelevant further opening 4, for example a gel port or such self-closingopening or valve. In an embodiment the end 31 of the tube 5 can beprovided with a connecting element 32, for example a clamping ring,click ring or dedicated connector for connecting the end 31 to thefurther opening 4 such that when the instrument 8 is retracted againsaid end 31 stays connected to said further opening 4. Alternatively theconnector 32 can be such that when the instrument 8 is retracted fromthe opening 4 the end 31 of the tube 5 stays connected to the instrument8, especially adjacent the tip 8′ thereof, such that the end 31 of thetube is pulled into the internal passage of the tube 5 when retractingthe instrument 8. Preferably the tube 5 is thereby made self-closing atleast near the end 31, such that the internal passage is closed offafter retraction of the tip 8′, or an element 35 such as for example anelastic band such as an O-ring is provided near the tip 8′, as shown inFIG. 6, which will be pulled off the tip 8′ closing the passage of thetube 5 when pulling the instrument tip 8′ back through the opening 4,which in this embodiment should be self closing. An advantage of suchembodiments may be that a tube 5 only has to be provided for an openingwhen it is to be used.

The disclosure is by no means limited to the embodiments specificallydescribed and shown in the drawings. Many variations therefor arepossible and are also considered disclosed herein, including but notlimited to all combinations and permutations of parts of the embodimentsas shown and described, which are all considered having been disclosedherein. The bag 1 may be made of any suitable material or combinationsof materials. In a bag having a multiple layered wall an inner wall maybe more rigid that an outer wall, in order to obtain expansionsubstantially outward if inflated between the layers. Multiple tissuereceiving openings could be provided. A bag 1 could have differentcompartments, some or all of which may be inflatable, whereas differenttissue may be receivable in such compartments.

The invention claimed is:
 1. A tissue receiving bag for use in surgery,wherein the bag comprises, upon insertion into a human or an animalbody, at least one tissue receiving opening for receiving tissue or aninstrument opening, wherein the bag further comprises, upon insertioninto the human or the animal body, at least one further opening into thebag, wherein a flexible tube extends from said at least one furtheropening having a free end comprising an insertion opening for insertingan instrument into the bag, wherein the flexible tube comprises at leasttwo closures or seals, longitudinally spaced apart, for closing theflexible tube or sealing against an instrument extending through saidflexible tube.
 2. The tissue receiving bag according to claim 1, whereinin an extended state of the flexible tube, the flexible tube has alength between the at least one further opening and the free end whichis at least five times a diameter of the at least one further opening.3. The tissue receiving bag according to claim 1, wherein in an extendedstate of the flexible tube, the flexible tube has a length suitable forduring use bringing the free end of the tube outside the human or theanimal body through a laparoscopic incision when the bag has beeninserted into a body cavity of the human or the animal body.
 4. Thetissue receiving bag according to claim 1, wherein the at least onefurther opening is spaced apart from the at least one of the at leastone tissue receiving opening or the instrument opening.
 5. The tissuereceiving bag according to claim 1, wherein the bag has a multi layeredwall part, wherein a gas or fluid can be provided between at least twoof the layers of said wall part.
 6. The tissue receiving bag accordingto claim 1, wherein at least part of a wall of the bag is at least oneof electrically conductive or reflective for electromagnetic waves. 7.The tissue receiving bag according to claim 1, wherein the bag has theat least one tissue receiving opening and the instrument opening, andwherein the instrument opening is spaced apart from the at least onetissue receiving opening.
 8. The tissue receiving bag according to claim1, wherein the bag is suitable for at least one of: introduction intothe human or the animal body through a first opening in the human or theanimal body; introducing tissue into the bag through the at least onetissue receiving opening; pulling a free end of the flexible tube outthrough a second opening in the human or the animal body; introducing amorcellator into the bag through the instrument opening; or introducinga further instrument into the bag through the free end of the flexibletube.
 9. The tissue receiving bag according to claim 8, which is furthersuitable for at least one of: containing morcellated tissue inside thebag; closure of the free end of the flexible tube outside the human orthe animal body; retracting the flexible tube into the human or theanimal body through the second incision; and retracting the bag from thehuman or the animal body through the first opening.
 10. A tissuereceiving bag for use in surgery, wherein the bag comprises, uponinsertion into a human or an animal body, at least one tissue receivingopening for receiving tissue or an instrument opening, wherein the bagfurther comprises, upon insertion into the human or the animal body, atleast one further opening into the bag, wherein a flexible tube extendsfrom said at least one further opening having a free end comprising aninsertion opening for inserting an instrument into the bag, wherein thebag is provided with the at least one additional further openingcomprising a series of further openings, wherein at least onecorresponding flexible tube extends from each additional further openingof the series of further openings.
 11. The tissue receiving bagaccording to claim 10, wherein the free end of a least one of theflexible tubes is provided with at least one closing element for closingthe free end of the flexible tube or for sealing the flexible tubearound an instrument inserted into the flexible tube through the freeend.
 12. The tissue receiving bag according to claim 10, wherein thefree end of a least one of the flexible tubes is closed, at least priorto use of the bag, by at least one of a tube portion, a closure or avalve.
 13. The tissue receiving bag according to claim 10, wherein theat least one further opening or additional further opening comprises aclosure or a seal for sealing around an instrument inserted through saidat least one further opening or additional further opening.
 14. A tissuereceiving bag for use in surgery, wherein the bag comprises, uponinsertion into a human or an animal body, at least one tissue receivingopening for receiving tissue or an instrument opening, wherein the bagfurther comprises, upon insertion into the human or the animal body, atleast one further opening into the bag, wherein a flexible tube extendsfrom said at least one further opening having a free end comprising aninsertion opening for inserting an instrument into the bag, wherein afurther tube extends from or defines the instrument opening, saidfurther tube comprising a closure or seal for closing or sealing thefurther tube around an instrument extending through said further tube orfor closing the further tube when said instrument is retracted from saidinstrument opening.
 15. An operating set for surgery, comprising atissue receiving bag according to claim 14, and at least one morcellatorinstrument, wherein at least one of the bag or the at least onemorcellator instrument comprise at least one detector and indicatorsystem for preventing the morcellator instrument from puncturing thebag.
 16. The operating set according to claim 15, further comprising atleast one further instrument insertable through at least one of theflexible tube or the at least one further opening of the bag, wherein atleast one of the at least one further opening or the flexible tube canbe sealingly closed around said at least one further instrument whenextending through at least one of said flexible tube or at least onefurther opening, wherein the at least one further instrument is one ofan endoscope, a camera, a catheter, a cannula, tongs, or scissors. 17.The tissue receiving bag according to claim 14, wherein the bag has theat least one tissue receiving opening and the instrument opening, andwherein the instrument opening is spaced apart from the at least onetissue receiving opening.
 18. A method for morcellating surgery using atissue receiving bag which comprises at least one tissue receivingopening, and an instrument opening, wherein the bag comprises at leastone further opening into the bag, wherein at least one flexible tubeextends from said at least one further opening having a free end,comprising at least the steps of: introduction of the tissue receivingbag into a human or animal body, through a first opening in the human orthe animal body; introducing tissue into the bag through the at leastone tissue receiving opening; closing the at least one tissue receivingopening; pulling the free end of the at least one flexible tube out ofthe human or the animal body; introducing a morcellator into the bagthrough the instrument opening; and introducing a further instrumentinto the bag through the free end of the at least one flexible tube. 19.The method of claim 18, wherein pulling the free end of the at least oneflexible tube out of the human or the animal body further comprises:pulling the free end of the at least one flexible tube out through asecond opening of the human or the animal body.
 20. The method accordingto claim 19, further comprising the steps of: morcellating the tissueinside the bag; containing the morcellated tissue inside the bag;closing the free end of the at least one flexible tube outside the humanor the animal body; retracting the at least one flexible tube into thehuman or the animal body through the second opening; and retracting thebag from the human or the animal body through the first opening.